Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
a r t i c l e i n f o s u m m a r y
Article history: Objective: The International Hip Outcome Tool (iHOT-33) is a questionnaire designed for young, active
Received 20 February 2016 patients with hip disorders. It has proven to be a highly reliable and valid questionnaire. The main
Accepted 30 August 2016 purpose of our study was to adapt the iHOT-33 questionnaire into simplified Chinese and to assess its
psychometric properties in Chinese patients.
Keywords: Method: The iHOT-33 was cross culturally adapted into Chinese and 138 patients completed the Western
iHOT-33
Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the EuroQol-5D (EQ-5D), and the
Simplified Chinese version
Chinese version of the iHOT-33(SC-iHOT-33) pre- or postoperatively within 6 months' follow-up. The
Hip disorders
Cronbach's alpha, intraclass correlation coefficient (ICC), Pearson's correlation coefficient (r), effect size
(ES), and standardized response mean (SRM) were calculated to assess the reliability, validity, and
responsiveness of the SC-iHOT-33, respectively.
Results: Total Cronbach's alpha was 0.965, which represented excellent internal consistency of the SC-
iHOT-33. The ICC ranges from 0.866 to 0.929, which shows excellent testeretest reliability. The sub-
scales of SC-iHOT-33 had the highest correlation coefficient (r ¼ 0.812) with the physical function
subscales of the WOMAC, as well as good correlation between the social/emotional subscale of the SC-
iHOT-33 and the EQ-5D (r ¼ 0.740, r ¼ 0.743). No floor or ceiling effects were found. The ES and SRM
values indicated good responsiveness of 2.44 and 2.67, respectively.
Conclusion: The SC-iHOT-33 questionnaire is reliable, valid, and responsive for the evaluation of young,
Chinese, active patients with hip disorders.
© 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.joca.2016.08.013
1063-4584/© 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
D.H. Li et al. / Osteoarthritis and Cartilage 25 (2017) 94e98 95
iHOT-33 are recommended for the assessment of young-to mid- patients signed the informed consent to participate in the study
dle-aged adults with hip pain5. and the clinical research ethics committee of our hospital approved
The iHOT-33 is the first evaluative tool designed to measure the study (No.CHEC2014-217). Additionally, the sample size met the
health-related quality of life in young, active patients with hip criterion from a previous study11, that suggested that the study
disorders6. The iHOT-33 has been studied and proven reliable, valid, should have at least 100 patients enrolled for an internal consis-
and responsive for patients with hip disorders4,6. It also has been tency analysis and 50 patients enrolled for floor or ceiling effects
translated into several languages such as German, Spanish, and and reliability and validity analysis. At the same time, we reviewed
Portuguese7e9. Therefore, this study aimed to perform a cross- a similar study8, and taking into account that some subjects would
cultural adaptation of the iHOT-33 for the Chinese-speaking pop- be lost to follow-up, we decided the sample size should be at least
ulation with hip disorders and evaluate the psychometric proper- 120 patients.
ties of the Chinese version in Chinese patients undergoing hip
arthroplasty. Instruments
Materials and methods The iHOT-33 questionnaire consists of four domains (symptoms
and functional limitations, sports and recreational activities, job-
Translation and cross-cultural adaptation related concerns, and social, emotional, and lifestyle concerns)
totaling 33 questions. Each question is answered through a visual
As previously described, the translation process has a standard analog scale (VAS) response format and generates an overall score
guideline, which we replicated10. There are five steps in the process. ranging from 0 to 100, with a higher score representing better hip
The translation from English to simplified Chinese was indepen- status. The final score is the average of the scores from the 33
dently performed by three bilingual translators and then the first questions. The iHOT-33 has been translated and validated into
Chinese version of the iHOT-33 was obtained after translation several languages at this point in time7e9.
disagreements were resolved by discussion. The back translation In order to evaluate the construct validity of the iHOT-33, we
was performed by three international medical students whose first compared it with the WOMAC and the EQ-5D. The WOMAC is a self-
language is English. Next, the first Chinese version and the English reported questionnaire used for patients with knee or hip osteo-
version were compared to solve any remaining problems and the arthritis (OA) and includes three subscales (pain, stiffness, and
final Chinese version of the iHOT-33 was obtained: the SC-iHOT-33. physical functioning) with 24 items. Each item is rated on a scale of
The final version was tested on 30 consecutive young patients with 0e4, and the final score of each subscale will be the summation.
hip disorders. The higher the score, the worse the quality of life it represents. The
EQ-5D is a standardized instrument used to measure health out-
comes. It is composed of two parts. Part 1 involves five questions
Participants
and scores range from 0.111 (worst quality of life) to 0.848 (best
quality of life). Part 2 offers a VAS for the patients through which
From August 2014 to May 2015, we invited a total of 150 patients
they score their physical health12. Both the WOMAC and the EQ-5D
with only one affected hip to participate in this study and 138
have been translated into simplified Chinese, with good validity,
consecutive young patients (84 males, 54 females) with hip disor-
reliability, and responsivity13,14 and have been used to evaluate the
ders were recruited. The inclusion criteria were as follows: age >18
construct validity of the iHOT-33 in other studies7,8.
years and <60 years, able to read and speak Chinese, hip disorders
Patients recruited in this study completed the SC-iHOT-33, the
diagnosed uniformly in our hospital and another hospital, active
WOMAC, and the EQ-5D when they decided to undergo THA in the
score 4 on a modified Tegner Activity Scale, and willing to receive
clinic. Two weeks later, prior to surgery, they were asked to com-
a total hip arthroplasty (THA) in our hospital. Patients were
plete the questionnaires for the second time. Six months after the
excluded if they were unable or unwilling to complete the ques-
THA, patients were required to complete the SC-iHOT-33 for the
tionnaire or if they had comorbid medical conditions that lead to
third time during a return visit.
hip pain or interfered with their ability to lead normal and activ-
ities6. The mean age of our participants was 43.3 years (range,
Statistical analysis
18e60 years). More detailed information is listed in Table I. All 138
Reliability ranged from 0.852 to 0.957 (see Table II). The SC-iHOT-33 showed
excellent testeretest reliability. Mean score of the retest was
We assessed the reliability of the SC-iHOT-33 by internal con- 32.36 ± 14.18 (mean ± SD), which was similar to the first test
sistency and testeretest reliability. Internal consistency was (32.65 ± 12.28) (mean ± SD). Moreover, the ICC value is
measured by Cronbach's alpha11. The value was judged as accept- 0.866e0.929 (Table III). As previously described, ICC >0.80 indi-
able (alpha >0.7), good (alpha >0.8), or excellent (alpha >0.9). cated excellent reliability18. In addition, we observed that each
Furthermore, we measured testeretest reliability by comparing the subscale enjoyed 100% scaling success rates and no scaling error
first and second time-points scores. The ICC was used to assess the existed. Moreover, no systematic error was discovered in the
testeretest reliability16, where a value > 0.6 was considered good BlandeAltman plots as we previously charted (Fig. 1).
reproducibility and a value > 0.8 was considered excellent. A
BlandeAltman plot not only described the mean scores of the two Validity
assessments and the differences between them, but it was used to
assess whether there was systematic bias between the test and The construct validity evaluation results obtained by comparing
retest of the SC-iHOT-3317,18. In addition, we calculated each sub- the SC-iHOT-33 subscales vs the WOMAC and the EQ-5D are shown
scale's scaling success rates to observe if any scaling error existed19. in Table III. The results were consistent with our prior hypothesis in
The subscale's scaling is the percentage of the items that correlate the pre-research period. The correlation between the SC-iHOT-33
higher with their own subscales than with the questionnaire's and the subscale of physical activities (0.802, P < 0.001) was
other domains. excellent. The subscales of symptoms and functional limitations in
the SC-iHOT-33 had the highest correlation coefficient of r ¼ 0.812
Validity with the physical function subscales of the WOMAC. The correla-
tion between the social/emotional subscale of the SC-iHOT-33 and
We evaluated construct validity by calculating Pearson's corre- the EQ-5D was good (r ¼ 0.740, r ¼ 0.743).
lation coefficients (r) among the SC-iHOT-33, the WOMAC, and the
EQ-5D. The construct validity was regarded as poor, fair, moderate, Responsiveness
good, or excellent when r ¼ 0e0.20, r ¼ 0.21e0.40, r ¼ 0.41e0.60,
r ¼ 0.61e0.80, or r ¼ 0.81e1.0, respectively20. Good construct val- The SC-iHOT-33 showed good responsiveness to surgery. The
idity means that a questionnaire correlates well with measures of responsiveness of the SC-iHOT-33 was evaluated by comparing the
the same construct (convergent validity) while poor construct pre- and postoperative scores. The mean score of the SC-iHOT-33
validity correlates with measures of different constructs (divergent improved from 32.65 ± 12.28 to 62.65 ± 9.07 with a mean
or discriminant validity). It was hypothesized that the physical, change of 30.00 ± 11.24. The ES and SRM for the SC-iHOT-33 were
mental, and social subscales in the SC-iHOT-33 were strongly 2.44(95% CI, 2.24 to 2.59) and 2.67(95% CI, 2.41 to 2.93),
correlated with those in the WOMAC and the EQ-5D. Under that respectively.
assumption, we calculated the r-value between each scale of SC-
iHOT-33, the WOMAC, and the EQ-5D. Discussion
Responsiveness Young patients with hip disorders have a higher demand for the
ability to return to sports, heavy physical activity, and quality of life
The responsiveness of the SC-iHOT-33 was evaluated by compared to older patients8. Therefore, it is not suitable to evaluate
comparing the preoperative and 6-month postoperative scores. In the operation effect by adopting ordinary scales developed for older
addition, we had the paired t-test of the scores in two rounds and patients. For example, the WOMAC has been widely used in clinics
calculated ES and SRM to determine responsiveness21. The ES was by Chinese orthopedic surgeons, but it is actually more suitable for
calculated by the mean change between the preoperative and 6- older patients with arthritis and was developed for use in an older
month postoperative results divided by the SD of the preopera- population.
tive score. The SRM was calculated by the mean change between In our opinions that the reason of arthroscopic surgery is not
the preoperative and 6-month postoperative results divided by the popular with orthopedic surgeons in China are complicated, the
SD of the change between preoperative and 6-month postoperative economic status of patients is one reason, but the primary reason is
results. arthroscopy's poor effect. Therefore, people will be more willing to
accept THA and patients undergoing THA in China are ideal can-
Results didates for the iHOT-33 adaption. Moreover, when Mohtadi et al.8
developed the iHOT-33, patients who underwent THA were part
Acceptability and score distribution of the inclusion criteria.
We evaluated the reliability by internal consistency and
The average time required to complete the SC-iHOT-33 was testeretest reliability. Each subscale of the SC-iHOT-33 contained
10.5 min, and participants expressed no difficulties in completing good internal consistency, as all Cronbach's alpha values were over
the questionnaire. We calculated the answering-loss ratio in the 0.8. As for the testeretest reliability, the ICC of each subscale was
four subscales, ranging from 0% to 5.1%. Owing to the particularity also over 0.8. The BlandeAltman plots proved that the SC-iHOT-33
of item 28, which relates to sexual activity, it had the highest had good reproducibility. In addition, the scaling success rates of all
answering-loss ratio (5.1%). The distribution of the scores among of the subscales were 100%, which implied that no scaling error was
the four subscales is displayed in Table II, and no floor (0%e found in each item. All the results discussed previously were
2.2% < 15%) or ceiling effect (0% < 15%) was detected. equivalent to other studies of the iHOT-339.
We evaluated the construct validity of the SC-iHOT-33 by
Reliability calculating the correlation between the SC-iHOT-33, the WOMAC,
and the EQ-5D. The obtained results nearly matched the previously
The ICC results were either very good or excellent for the sub- presumed results. It is suggested that the SC-iHOT-33 had very
scales. Cronbach's alpha was 0.965 for the overall SC-iHOT-33 and good convergent validity and divergent validity. It was evident that
D.H. Li et al. / Osteoarthritis and Cartilage 25 (2017) 94e98 97
Table II
Distribution and internal consistency for the subscales of the SC-iHOT33*
Subscale Mean ± SD Missing items Observed range Theoretical range Floor Ceiling Scaling Cronbach's ES
n (%)y effect (%)z effect (%)z success (%)x alpha
SC-iHOT33: Simplified Chinese version of the International Hip Outcome Tool-33; SD: Standard deviation.
*
The sample size for the analysis of score distribution and internal consistency was 138.
y
Number of patients with some missing items in the subscale, and the ratio in parentheses is the questionnaires exists missing items.
z
Percentage of patients with the worst (floor effect) and the best (ceiling effect) score.
x
Percentage of the items that correlate higher with their own subscales than with the other domains of the questionnaire.
Table III
Construct validity, reliability, and responsiveness of the SC-iHOT33*
Symptom (16) Sports (6) Job (4) Social (7) Total (33)
SC-iHOT33: Simplified Chinese version of the International Hip Outcome Tool-33; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index; EQ-5D:
EuroQol-5 Dimensions; SD: Standard deviation; ICC: Intraclass correlation coefficient; CI: Confidence interval; THR: Total Hip Replacement; SRM: Standardized response
mean.
*
The sample size for the analysis of construct validity, reliability, and responsiveness was 138.
have arthroplasty rather than arthroscopy, which might lead to 6. Mohtadi NGH, Griffin DR, Pedersen ME, Chan D, Safran MR,
better responses to surgical treatment. Parsons N, et al. The development and validation of a self-
However, a few limitations of this study should be addressed. administered quality-of-life outcome measure for young,
First, cultural diversity about sex is obvious. The 28th question, active patients with symptomatic hip disease:the International
“How much trouble do you have with sexual activity because of Hip Outcome Tool (iHOT-33). Arthroscopy 2012;28(5):
your hip?” had the highest answering-loss ratio. As the previous 595e605.
study explained, the reasonable explanation is that the Chinese 7. Baumann F, Weber J, Zeman F, Müller M, Lahner M, Nerlich M,
culture is more private and people are ashamed to talk about sex or et al. Validation of a German version of the International Hip
sexual activity in public14. Second, all the patients in our study Outcome Tool (G-iHOT33) according to the COSMIN checklist:
selected THA rather than arthroscopic surgery, therefore it is how much improvement is clinically relevant? Arch Orthop
necessary to recruit patients undergoing arthroscopic surgery in Trauma Surg 2016;136(1):83e91.
the future. 8. Ruiz-Iban MA, Seijas R, Sallent A, Ares O, Marín-Pen ~ a O,
Muriel A, et al. The International Hip Outcome Tool-33 (iHOT-
Summary 33): multicenter validation and translation to Spanish. Health
Qual Life Outcomes 2015;13:62.
This study confirmed that the iHOT-33 could be translated into 9. Polesello GC, Godoy GF, Trindade CA, de Queiroz MC, Honda E,
simplified Chinese with good psychometric properties. As a self- Ono NK. Translation and cross-cultural adaptation of the In-
reported questionnaire, the SC-iHOT-33 is a joint-specific, reliable, ternational Hip Outcome Tool (iHOT) into Portuguese. Acta
valid instrument for young Chinese patients undergoing hip Ortop Bras 2012;20(2):88Be92B.
arthroplasty for hip disorders. Therefore, we recommend that 10. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines
surgeons in clinics use the iHOT-33 to evaluate the impact of hip for the process of cross-cultural adaptation of self-report
discomfort and help assess the treatment effects on patients measures. Spine Phila Pa 1976;2000(25):3186e91.
younger than 60 years old. 11. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL,
Dekker J, et al. Quality criteria were proposed for measure-
ment properties of health status questionnaires. J Clin Epi-
Author contributions
demiol 2007;60(1):34e42.
Dahe Li, Wei Wang, and Xia Li contributed equally to the manu-
12. Wang W, He CR, Zheng W, Li J, Xu WD. Development of a valid
script, they conceived and designed the study and performed the
simplified Chinese version of the Osteoarthritis of Knee and
statistical analysis; Yulei Gao, Denghui Liu, and Delin Liu collected
Hip Quality of Life (OAKHQOL) in patients with knee or hip
the clinical data; Weidong Xu Approved the final version.
osteoarthritis. J Eval Clin Pract 2015;4.
13. Xie F, Li SC, Goeree R, Tarride JE, O'Reilly D, Lo NN, et al.
Conflict of interest
Validation of Chinese Western Ontario and McMaster Uni-
There is no conflict of interest.
versities Osteoarthritis Index (WOMAC) in patients sched-
uled for total knee replacement. Qual Life Res 2008;17(4):
Acknowledgements 595e601.
14. Wang HM, Patrick DL, Edwards TC, Skalicky AM, Zeng HY,
We are grateful for the help of three international medical Gu WW. Validation of the EQ-5D in a general population
students for the translation. We also show a sincere gratitude to the sample in urban China. Qual Life Res 2012;21(1):155e60.
guidance of statistical analysis from associate professor Xia Li. This 15. Coste J, Fermanian J, Venot A. Methodological and statistical
study has no funding sources. problems in the construction of composite measurement
scales: a survey of six medical and epidemiological journals.
References Stat Med 1995;14(4):331e45.
16. Landis JR, Koch GG. The measurement of observer agreement
1. Schenker ML, Martin R, Weiland DE, Philippon MJ. Current for categorical data. Biometrics 1977;33(1):159e74.
trends in hip arthroscopy: a review of injury diagnosis, tech- 17. Bland JM, Altman DG. Statistical methods for assessing
niques and outcome scoring. Curr Opin Orthop 2005;16:89e94. agreement between two methods of clinical measurement.
2. Thorborg K, Roos EM, Bartels EM, Petersen J, Ho €lmich P. Val- Lancet 1986;1(8476):307e10.
idity, reliability and responsiveness of patient-reported 18. Bland JM, Altman DG. Measuring agreement in method com-
outcome questionnaires when assessing hip and groin parison studies. Stat Methods Med Res 1999;8(2):135e60.
disability: a systematic review. Br J Sports Med 2010;44(16): 19. Gandek B, Ware Jr JE, Aaronson NK, Alonso J, Apolone G,
1186e96. Bjorner J, et al. Tests of data quality, scaling assumptions, and
3. Tijssen M, van Cingel R, van Melick N, de Visser E. Patient- reliability of the SF-36 in eleven countries: results from the
reported outcome questionnaires for hip arthroscopy: a sys- IQOLA Project. International Quality of Life Assessment. J Clin
tematic review of the psychometric evidence. BMC Muscu- Epidemiol 1998;51(11):1149e58.
loskelet Disord 2011;12:117. 20. Wei X, Wang Z, Yang C, Wu B, Liu X, Yi H, et al. Development of
4. Kemp JL, Collins NJ, Roos EM, Crossley KM. Psychometric a simplified Chinese version of the Hip Disability and Osteo-
properties of patient-reported outcome measures for hip arthritis Outcome Score (HOOS): cross-cultural adaptation and
arthroscopic surgery. Am J Sports Med 2013;41(9):2065e73. psychometric evaluation. Osteoarthritis Cartilage 2012;20(12):
5. Thorborg K, Tijssen M, Habets B, Bartels EM, Roos EM, Kemp J, 1563e7.
et al. Patient-reported outcome (PRO) questionnaires for 21. Husted JA, Cook RJ, Farewell VT, Gladman D. Methods for
young to middle-aged adults with hip and groin disability: a assessing responsiveness: a critical review and recommenda-
systematic review of the clinimetric evidence. Br J Sports Med tions. J Clin Epidemiol 2000;53(5):459e68.
2015;49(12):812.